MDCG: proposed template and Q&A for the trend report

[2025-09-18] On September 18, 2025, the Post-Marketing Surveillance and Vigilance working group of the MDCG (Medical Device Coordination Group) posted a number of working documents on the European Commission‘s website relating to the “trend report”.

These documents are part of the list of 7 documents (guidelines and other deliverables) planned by the working group for the year 2025 (see previous network article).

The published page includes the following proposals:

• agendas of the meeting held on February 11 and 12, 2025
• minutes of the meeting
• as well as the latest proposals for working documents from the “Post-Marketing Surveillance and Vigilance” group.

Context

Under Article 88 of Regulation (EU) 2017/745 on medical devices (MDR) and Article 83 of Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDMD), manufacturers must report to the competent authority or authorities any statistically significant increase in the frequency or severity of non-serious incidents and expected adverse reactions (MDR) or expected erroneous results (IVDMD). These two articles of the regulations are entitled “Trend reporting”.

Objectives

The documents proposed by the MDCG “Post-market surveillance and vigilance” group are designed to help manufacturers :

• identify the information to be provided to the competent authority in addition to the Manufacturer Trend Report (MTR), which must be submitted to the European medical device database EUDAMED;
• clarify the minimum information required to prepare the trend report.

Summary of main documents

1. the first 6-page working document specifies :

• the 2 components of a trend report: form and document,
• the submission process: what to do while waiting for the EUDAMED vigilance module to become mandatory, and what to do afterwards,
• the expected content of the trend report: description of the device impacted by the statistically significant increase, description of the trend (method used, justification for the length of analysis, type of trend, number of events reported per country, etc.), analysis of the trend report with an initial and a final report (preliminary results, conclusions of the investigations carried out, impact on the benefit-risk analysis, etc.) and description of the measures/actions taken.), analysis of the trend report with an initial and final report (preliminary results, conclusions of the investigations carried out, impact on the benefit-risk analysis, etc.) and description of the measures/actions taken (details, measure of effectiveness, monitoring, corrective safety measures initiated, justification for no action, etc.).

Please note that manufacturers are required to use the IMDRF codes for adverse event terminology when submitting a trend report. This document is to be used in conjunction with the proposed MTR form described below under point 2.

2. The MTR form (6 pages) asks for the identification data of the entity and the device concerned, as well as other information detailed in point 1.

3. The 20-page “Questions and Answers” (Q&A document) provides practical clarifications on the significant increase. It presents how to manage the requirements according to the regulatory status of the devices (old devices, legacy devices, devices under MDR or IVDR regulations), integration into the Quality Management System, management scenarios for knowing when to submit a new report, examples of events to be reported, and more.

The published page includes other related documents, a proposal for version 6 of the Field Safety Corrective Action (FSCA) form (5 pages), a presentation (13 pages) focusing on discussions relating to sections 89(6) of the MDR and 84(6) of the IVDR – which deals specifically with devices containing ancillary medical substances or products and companion diagnostic tests – and a detailed presentation (13 pages) setting out the status of discussions for the trend report.

Conclusions

In conclusion, we particularly recommend reading both the Q&A (very useful for answering manufacturers’ operational questions) and the detailed presentation (useful for grasping the group’s progress and orientations), on a subject that has raised many questions since the regulations were published.

Article written by Lam-Xé NOEL, Managing Director of DM Experts SAS.